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the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices

On May 5, 2017 the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC was published in the Official Journal of the European Union.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 26 May 2020. By way of derogation, see the Article 123 Entry into force and date of application.


Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices

On May 5, 2017 the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU was published in the Official Journal of the European Union.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 26 May 2022. By way of derogation, see the Article 113 Entry into force and date of application.


Electronic communication – restriction of attachments in ZIP format.

ITC applied the restriction by which it will not be possible to deliver the electronic message with an attachment in ZIP format.

For delivery of large quantities of electronic documents, use a different method than compress into ZIP format.

Thank you for your understanding.


Termination of the contractual cooperation with the company Sastek, Turkey

On 31st August 2015 was terminated a contractual cooperation with the Turkish sales representative of ITC - the company “SASTEK Conformity Assessment Services Co.”.


nanotechnology - the analytical laboratory of ITC engage in cooperation with the Technical University of Dresden

The analytical laboratory of ITC engage in cooperation with the Technical University of Dresden in the project " nanotechnology – guidance on detection and identification of nano-objects in complex matrixes", which is demanded by the French Bureau of Standards (Association Francaise de Normalisation).


Personal protective equipment

Products certification, CE » Conformity assessment (CE)

Personal Protective Equipment (PPE), prior to its introduction to the market, is subject to mandatory conformity assessment in terms of its safety. The basic requirements for personal protective equipment are defined by Council Directive 89/686/EEC. The PPE, in accordance with the risk analysis, is divided into 3 categories within the prescribed manner for the EC conformity assessment. For the categories with a higher level of risk (categories II and III) the compulsory participation of the authorised person (notified body) is prescribed; for a simpler type (category I), the manufacturer may conduct the EC conformity assessment itself, without the participation of the authorised person. Every item of PPE is labelled with the CE marking and the manufacturer or the authorised representative issues an EC declaration of conformity.

 

Application for conformity assessment   Application for quality control system inspection
 
Client's Handbook (PDF)   Searching the database of certificates  


SERVICES PROVIDED IN CONNECTION WITH CONFORMITY ASSESSMENT OF PERSONAL PROTECTIVE EQUIPMENT

  • Conformity assessment by the Notified Body No. 1023 according to the requirements of the Council Directive 89/686/EEC, laying down the technical requirements for personal protective equipment
    • Assessment of the PPE of category I
      For the simple personal protective equipment in the first category it is sufficient for the manufacturer or the importer to assess the conformity. The accredited testing laboratory or certification authority can be requested to carry out the tests and their evaluation. The Notified Body (NB) does not undertake such evaluations.
    • Assessment of the PPE of the categories II and III
      For the PPE in the second category, its manufacturer or importer provides, prior to the commencement of its serial production and introduction to the market a conformity assessment for the type of the Personal Protective Equipment through the EC type examination by the Notified Body.For the PPE in the third category the manufacturer or the importer shall provide the EC type examination in the same manner as for the PPE in the second category and additionally they will undertake regular checking of Personal Protective Equipment produced.
  • Testing PPE in the Accredited Laboratory No. 1004 and No. 1004.3
  • Granting licences for the voluntary certification mark “ITC certified quality
    ITC grants a license for the use of the quality mark, which is granted to the products where high standard of safety and quality parameters has been proved by certification and where meeting the prerequisites of the producer for continuous quality compliance has been proved through inspection visits.
  • Standardization services (standardization) and technical information.
  • Certification of management systems (ISO 9001, ISO 14001, OHSAS 18001)
  • Technical inspection

PRODUCTS ASSESSED IN ITC ACCORDING TO the Council Directive 89/686/EEC

  • Institute for Testing and Certification, Inc. is notified as the Notified Body No. 1023 for conformity assessment of the following personal protective equipment (PPE):
  • PPE for protection of head
  • PPE for protection of eyes
  • PPE for protection of hands
  • PPE for protection of body
  • PPE for protection of legs
  • PPE for sport activities

CONTACTS

Person Phone fax e-mail
Ing. Elena Tomanová +420 577 601 370 +420 577 104 855 etomanovaPostaitczlin.cz


Post address:
Institute for testing and certification, a.s.
trida Tomase Bati 299, Louky, 763 02 Zlin
Czech Republic

The person responsible for accuracy of data: Ing. Elena Tomanová

Updated: 10.1.2017
 
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